Pediatric transplant
As of December 8, 2020, OPTN bylaws require transplant candidates younger than age 18 to be listed at transplant programs that have been approved to have a pediatric component. The searchable member directory on the OPTN website displays the transplant programs who are approved to perform pediatric transplants.
On and after that date, any liver or heart transplant program that does not have an approved pediatric component, but has a potential pediatric candidate it believes cannot be transferred and must be transplanted on an imminent basis, must submit an exception request to the OPTN.
Background
The OPTN Board of Directors approved bylaws in December 2015 establishing requirements for pediatric components of transplant programs, including minimum training and experience qualifications for primary pediatric transplant surgeons and physicians at kidney, liver and heart programs.
Implementation of these bylaws was postponed to allow time for members of the transplant community to prepare for the changes, as well as to allow for development and approval of required documentation by the federal Office of Management and Budget (OMB).
Transplant programs choosing to have a pediatric transplant component submitted applications to the OPTN in 2019, documenting their adherence to the criteria established in the bylaws. The OPTN Board of Directors will formally approve each of the programs that meet the requirements at its scheduled meeting in December 2020.
After the initial set of program approvals, a transplant program that wishes to apply for a pediatric program component may do so, provided it meets the criteria established in the bylaws.
Education
Listing pediatric candidates under emergency exception
As of Dec. 8. 2020, OPTN members who do not have an approved pediatric component for their liver or heart programs may list pediatric candidates (less than 18 years of age) for those organ types under a new emergency membership exception pathway if the candidates meet certain criteria.
The fields for emergency membership exceptions are being added to the status 1A justification forms in UNetsm. Prior to filling out the forms, make sure that you have the necessary documentation.
You must consult the primary pediatric physician or surgeon at an approved pediatric component of the appropriate type to confirm that it is not medically advisable to transport the patient to a different location. You must maintain documentation of the consultation. When you complete the justification form, you must also report the name of the consulting primary pediatric physician or surgeon and his/her transplant hospital.
To list a pediatric heart patient under the emergency exception pathway:
- The patient must meet the requirements for pediatric status 1A. This does not include status 1A by status exception.
- The patient must be admitted to the transplant hospital and be supported by either a surgically implanted, non-endovascular VAD that is not FDA-approved for out of hospital use for any age group, or by VA ECMO
There will be a new section in the Heart Status 1A form for any hospital that does not have an approved pediatric heart component to document this information.
To list a pediatric liver patient under the emergency exception pathway:
- The patient must meet the requirements for pediatric status 1A. This does not include status 1A by status exception.
There will be a new section in the Liver Status 1A form for any hospital that does not have an approved pediatric liver component to document this information.
To maintain the emergency membership exception for your candidate:
- The candidate’s clinical status must continually meet the emergency membership exception requirements
- You must maintain documentation demonstrating the candidate’s clinical status
- You must follow normally established procedures and timelines for recertifying the candidate’s status by extending their justification form
For information on status recertification, refer to OPTN Policy. If at any time your candidate no longer meets the criteria for the emergency membership exception, you must remove the candidate from the waiting list within 24 hours and assist the candidate in transferring to another transplant program with an approved pediatric component.
Applying for a pediatric component for a transplant program
If you are interested in applying for a pediatric component for your transplant program, please send an e-mail to membershiprequests@unos.org or call (833) 577-9469. This podcast describes criteria needed to apply for a pediatric component.
Resources
OPTN Bylaws
- Establish pediatric training and experience (8/2015)
- Updated policy notice (PDF; 7/2018)
- Original policy notice (PDF; 1/2016)
- Bylaws language without lines and strikeouts (503K PDF; 12/2018)
- Revise pediatric emergency membership exception pathway (7/2017)
- Policy notice (293K PDF; 12/2017)
Additional resources
- Guidance for Pediatric Heart Exception Requests (PDF; 2/2021)
- Listen to the pediatric bylaw application process podcast(11/2019)
- Frequently asked questions (PDF; updated 7/2019)
- Pediatric committee update (PDF; 8/2019)
- Pediatric transplantation committee
- Pediatric transition and transfer guidance (PDF; 12/2018)
- Ethical principles of pediatric organ allocation (6/2014)
- What every parent needs to know: Transplant guide, by parents for parents (5M PDF; 4/2018)